Suspected Falsified Alert
| DRAP Alert No | NoI/S/10-22-28 |
| Action Date | 25th October, 2022 |
| Target Audience | 1. Regulatory Field Force 2. Pharmacists and Chemists at Distribution, Pharmacies and Medical Stores 3. Healthcare Professionals- Physicians, Pharmacists, and Nurses at hospitals, Clinics and Healthcare Institutions 4. General Public |
| Problem Statement | During the market surveillance activities in different areas of Karachi, Provincial Drug Inspectors from Karachi have identified the suspected samples of products and sent for analysis to Drug Testing Laboratories. The Provincial Drugs Testing Laboratory, Sindh, Karachi has declared the samples of following products as spurious. The stated manufacturers on the labels of these products has informed that they have not manufactured these batches. Details are as under: – |
| Sr | Product Name | Batch # | PURPORTED TO BE MANUFACTURED BY |
|---|---|---|---|
| 1 | Cap Rulling 40mg | 4RU083 | M/s. High-Q Pharma Karachi. |
| 2 | Cap Eskeem 40mg | 4EK086 | -do- |
| 3 | Cap Mixel 400mg | 4MX120 | -do- |
| 4 | Tab Dicloran 50mg | 002H | M/s. Sami Pharma Karachi |
| 5 | Inj Meronem IV 1g | 4A21D282 4A21H02 4B21K26 | M/s. ACS Doblar & packed by Ms. Pfizer Pakistan Ltd. |
| 6 | Inj. Tanzo 2.25g | PN20148 | M/s. Bosch Pharma Karachi |
| 7 | Inj. PENRO 500mg | PO210047 | -do- |
| 8 | Tab. Ciproxin 500mg | BAA058 | M/s. Bayer Pakistan Ltd Karachi |
| 9 | Cap Azomax 250 | PMSA | M/s. GlaxoSmithKline Ltd. |
| 10 | Tab. Relief Extra Finished (Packed strips) | Not mentioned | M/s. Combitic Global Caplet, India |
| Action Initiated | The Regulatory Field Force has been directed to increase the market surveillance and confiscate these batches of above-mentioned products. All Pharmacists and chemists working at distributions and Pharmacies should immediately check the stock and stop supplying these batches of products. The remining stock should be quarantine immediately, and supplier(s) information should be provided to the Regulatory field force (DRAP, Provincial Health Departments and States) in order to ensure the removal of above-mentioned batches of products. |
| Advice for Healthcare Professionals | -DRAP requests increased vigilance within the supply chains of institutions/pharmacies/healthcare facilities likely to be affected by these batches of above-mentioned products. -Adverse reactions or quality problems experienced with the use of these product shall be reported to the National Pharmacovigilance Centre(NPC), DRAP using Adverse Event Reporting Form or online through this link. -Please click here for further information on problem reporting to DRAP. |
| Advice for Consumers | -Consumers should stop using these products bearing the affected batch number(s) and shall contact to their physician or healthcare provider if they have experienced any problems that may be related to taking or using any these drug products, and report the incident to Drug Regulatory Authority of Pakistan / National Pharmacovigilance Centre. -All therapeutic goods must be obtained from the licensed pharmacies, and other authorized / licensed retail outlets. The authenticity and condition of products should be carefully checked. Seek advice from your pharmacists or other healthcare professionals in case of any doubt. |